Retractable needle catheter delivery apparatus

ABSTRACT

A catheter insertion system includes a housing extending along a longitudinal axis. A needle extends distally from a distal end of the housing. The needle has a longitudinal passage coaxially aligned with the housing. A catheter has a length and is sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position with at least a portion of the catheter length extending beyond a distal tip of the needle. The needle is typically configured to be retracted back into the housing after the catheter has been advanced, thus providing an integrated catheter and catheter insertion apparatus. After needle retraction, the housing may be taped to the patient&#39;s skin while the needle remains protected within the housing. A luer on the catheter may then be connected to a fluid or other source in an otherwise conventional manner.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Application No.PCT/US2020/061633, filed Nov. 20, 2020, which claims the benefit of U.S.Provisional No. 63/023,699, filed May 12, 2020; U.S. Provisional No.62/985,182, filed Mar. 4, 2020; U.S. Provisional No. 62/941,541, filedon Nov. 27, 2019, and U.S. Provisional No. 62/941,211, filed on Nov. 27,2019, the disclosures of which are fully incorporated herein byreference; this application also claims the benefit of U.S. ProvisionalNo. 63/144,258, filed Feb. 1, 2021.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to the field of medical devicesand methods. More particularly, the present invention relates tocatheter insertion devices, through-the-needle catheters, and relatedmethods of their use.

Catheters are used in various medical procedures to administer fluids toa patient and/or to withdraw body fluids from a vein of a patient.Catheters are generally made of a flexible plastic material or variouspolymers, and a needle is used to access a vein or artery in the body inorder to introduce the catheter into a blood vessel. One catheterinsertion technique is known as the “through-the-needle” technique. Inthis technique, the needle is inserted through the skin and into theblood vessel until the needle tip is properly located in the vessel.Proper location of the needle tip is usually noted by a small flow ofblood through the needle and into a flash chamber in a needle hub. Afterthe needle is in proper position, a catheter is advanced through theneedle and into the vessel. The needle is then withdrawn from the body,leaving the catheter implanted with the distal end of the catheterlocated in the vessel. However, typically, the needle cannot be easilyremoved and disposed of because of the interference of the catheter hubat the proximal end of the catheter. Accordingly, a common solution tothis problem with the through-the-needle catheter is to remove theneedle from the catheter by splitting the needle. For example, theneedle may be made splittable by forming the needle of twolongitudinally aligned halves, or by longitudinally scoring orperforating the body of the needle.

However, even with a splittable needle, the portions of the needlepresent a safety/disposal risk. Furthermore, the catheter is typicallymanipulated by an operator while threading the catheter through thelumen of the needle. As a result, catheters are often contaminated bybacteria from the skin of the patient or due to manipulation by theoperator.

US2019/0076628, commonly assigned with the present application,describes a splittable needle catheter insertion tool where the catheteris held free from contamination prior to and during penetration of theneedle to a patient's target vein. The design of the splittable needlecatheter insertion tool is a significant advance in the art but stillrequires a separate needle/handle removal step during deployments aswell as disposable of the needle at the point of use.

It would thus be desirable to provide needle-type catheter insertiontools which do not require splitting or other disassembly of theinsertion tool at the time of catheter insertion. It would be furtherdesirable that any such catheter insertion tools be inherently safe andnon-traumatic to the patient in use, and in particular reduce any riskof accidental needle sticks to medical personnel as well as the patient.At least some of these objectives will be met by the inventionsdescribed and claimed below.

2. Listing of the Background Art

US2019/0076628 is described above. Other relevant patents andpublications include U.S. Pat. Nos. 8,974,411; 4,957,489;US2017/0209671; US2019/328954; US2019/314614; US2019/351192;US2019/201667; US2009/264825; US2004/116855; U.S. Pat. Nos. 10,525,236;10,238,840; 9,162,037; 5,935,110; 5,911,705; and 5,129,884.

SUMMARY OF THE INVENTION

In a first aspect, the present invention provides a catheter insertionsystem which includes both a catheter insertion device and a catheter tobe inserted into a patient's venous system using the catheter insertiondevice. The catheter insertion device includes a housing extending alonga longitudinal axis and a needle extending distally, usually coaxially,from a distal end of housing. The needle will typically have alongitudinal passage coaxially aligned with the longitudinal axis of thehousing. The catheter will typically be configured (typically having asuitable length, diameter, and shaped) to allow the catheter to beadvanced from a retracted position within the longitudinal passage inthe needle to an extended position beyond a distal tip of the needle,typically having from 25% to 90%, usually from 50% to 75%, of thecatheter length extending beyond the distal end of the needle when thecatheter is in its extended position. The needle will be configured tobe retracted back into the housing after the catheter has been distallyadvanced through the needle. In this way, the needle can be safelysequestered within the housing, and the housing can be secured to thepatient, typically being taped or otherwise secured to a location on thepatient's skin adjacent the catheter entry location.

In exemplary embodiments, the catheter insertion tool will furthercomprise a slider which is typically coupled to a proximal end of theneedle. The slider maybe mounted on an outer surface of the housing sothat a user may manually retract the needle in a proximal directionafter the catheter has been advanced through the needle in a distaldirection. In specific embodiments, the slider may be configured to beretracted through or within an axial slot on the housing. In manyembodiments, the needle and/or the slider will be configured to preventdistal advancement of the needle after the needle has been retracted. Inmany instances, the catheter of the present invention will have anatraumatic distal tip. For example, the catheter may have a bullet tipwhere a port is formed within or through the bullet tip, typically bychamfering a hemispherical or other rounded surface of the bullet tip atan angle to provide a laterally deflected flow from the distal tip ofthe catheter. For example, the port may be chamfered or otherwiseorientated at an angel from 35° to 75° relative to a longitudinal axisof the catheter were the distal end period.

In a particular aspect of the present invention, the venous or otherluminal access catheter has a distal port configured to direct an outletflow in a lateral direction (relative to the axial direction of theneedle). The distal port has a fixed rotational orientation relative tothe longitudinal axis of the housing. In this way, a user can readilycontrol a rotational orientation of the distal port of the catheter asthe catheter is being advanced from the needle. Usually, the user willrotationally orient the catheter insertion device which carries thecatheter so that the distal port on the catheter is deployed in adesired rotational orientation in the venous lumen. Typically, thedistal region of the catheter will be advanced against a wall of thevenous lumen and the distal port will be oriented to direct fluid flowfrom the distal port toward the center of the venous lumen. Suchorientation is advantageous as it promotes mixing of the fluid with agreater blood flow.

In other particular embodiments of the present invention, the port maybe configured to orient the outlet flow at an angle in a range from 30°to 75° relatively to a longitudinal access of the catheter near itsdistal end.

In other specific aspects, the catheter may have an atraumatic tip, suchas a bullet tip and the outlet port may be formed by a chamfer angled onone side of the bullet tip.

In a second aspect, the present invention provides a method forinserting a catheter into a vein. The method comprises manuallyadvancing a needle extending distally from the housing into the vein. Acatheter is manually advanced from the needle so that a distal port ofthe catheter lies at a desired location in a venous or other vessellumen. The needle may then be manually retracted over the catheter andinto the housing. After the catheter is thus deployed, the housing maybe secured to a skin region of the patient, typically adjacent to thecatheter insertion site, and a fluid source may be connected to aconnecter at a proximal end of the catheter.

In particular method embodiments, the catheter has an atraumatic tip,such as a bullet tip, and the port may be formed by chamfering one sideof the bullet tip, for example being oriented at an angle from 30° to75° relative to a longitudinal axis of the catheter near the distal end.The methods may further comprise releasing a fluid from anon-longitudinally oriented port in a direction across a blood flow topromote mixing. For example, the distal region of the catheter will beadvanced to lie along one side of a venous wall, where the user pointsthe outlet port to direct fluid flow toward a center of the venouslumen, promoting mixing.

In still further aspects, the present invention provides an integratedcatheter insertion apparatus comprising a housing, a needle, and avenous access catheter. By “integrated,” it is meant that the housing,the needle, and the catheter are provided as a single assembly orstructure. In particular, while various components of the singleassembly will be rearranged during use, the components of the integratedapparatus are intended to be used together without disassembly and theapparatus will include a luer or other connector for subsequentattachment to external devices and equipment for both venous access forvarious purposes including delivery of intravenous fluids, drugs, bloodtransfusions, and the like as well as drawing blood and othertreatments.

Any of these catheter insertion apparatuses may further comprising avalve in the luer or other proximal connector where the valve isconfigured to open in response to engagement with an external connectorwhen the external connector is attached to the proximal connector. Forexample, the valve in the proximal connector may comprise a split valvethat opens when advanced distally against a male rod or other fitting inan axial passage in the proximal connector.

In particular, a second exemplary embodiment of the catheter insertionapparatus according to the present invention comprise an integratedstructure comprising housing having a longitudinal passage. A needle isslidably mounted within the longitudinal passage of the housing and hasan axial lumen extending from a proximal end to a tissue-penetratingdistal tip. A catheter is slidably mounted within the needle lumen andhas a distal port and a proximal connector. In an initial configurationof the catheter insertion apparatus, the needle extends distally of thehousing and the catheter is retracted proximally within the needle. Theproximal connector of the catheter is distally advanceable to engage aproximal end of the housing. Such distal advancement extends the distalport of the catheter distally from the distal tip of the needle, and theneedle is fully retractable over the catheter and within the housingafter the catheter has been distally advanced.

In exemplary embodiments, the needle will typically have a length in arange from 0.5 cm to 3 cm, often having a length of 1.5 cm, butsometimes having a length or 1 cm or shorter. The catheter may have anexposed length (catheter tube length when fully extended distally fromthe housing) in a range from 2 cm to 8 cm, typically having an exposedlength of 3 cm to 6 cm.

In particular embodiments, a spring assembly is disposed within thelongitudinal passage of the housing and configured to retract the needleafter the catheter has been distally advanced from the needle.Typically, the spring assembly is configured to automatically retractthe needle after the catheter has been fully distally advanced from theneedle. In specific instances, the spring assembly comprises a coiledspring disposed coaxially over the needle and a locking mechanism thatholds the needle it its distally advanced position with the spring in anaxially compressed configuration. Release of the locking mechanismallows the spring to axially expand, driving the needle proximally toretract the needle fully within the housing. In specific instances, thelocking mechanism may be configured to automatically release the springwhen the catheter is fully advanced and/or when the catheter retractionmechanism is actuated. Alternatively, in some embodiments, the springassembly could be configured to be manually released, e.g. by a buttonor other trigger on the housing.

In further specific aspects, the catheter locks within the housing afterthe catheter has been fully advanced. In still other particularembodiments, the housing will be configured to be taped or otherwisesecured to the patient after the needle has been retracted. In stillfurther specific instances, the proximal connector of the cathetercomprises a luer fitting for attachment to external structure, such asfluid delivery tubing, used in conventional medical systems.

In still further aspects of the present invention, a catheter insertionapparatus comprises a housing having a longitudinal passage. A needleassembly is slidably mounted within the longitudinal passage of thehousing and has an axial lumen extending from a proximal carriage to atissue-penetrating distal tip. Typically, a needle of the needleassembly extends distally from a distal end of the housing when thecatheter insertion apparatus is in an initial configuration. Theapparatus further comprises a catheter assembly including a catheterslidably mounted within the needle lumen. The catheter typicallyincludes a distal port, a proximal connector, and at least one armextending distally from the proximal connector. The catheter istypically retracted proximally within the needle in an initialconfiguration of the catheter insertion apparatus. The apparatus usuallyfurther comprises an axially compressed coil spring disposed coaxiallyover a proximal portion of the needle. The coil spring has a distal endengaging an interior surface of the longitudinal passage of the housingand a proximal end engaging a distal face of the proximal hub of theneedle when the insertion apparatus is in its initial configuration. Alocking disc is configured to hold the coil spring in its axiallycompressed configuration. Usually, the locking disc is furtherconfigured to be engaged by the at least one arm of the catheterassembly when the catheter assembly is distally advanced relative to thehousing. Typically, rotation of the catheter assembly after it has beenfully advanced will release the locking disc, thus allowing the springto axially expand to retract the needle. In particular instances of thecatheter insertion apparatus of the present invention, prior to rotationof the catheter assembly, the locking disc engages one or more retainingfeatures on an interior surface of the longitudinal passage. In suchinstances, rotation of the catheter assembly causes the locking disc torotate and disengage from the one or more retaining feature, thusallowing the coil spring to expand and proximally retract the needleassembly.

In still further particular embodiments, a distal end of the at leastone arm of the catheter assembly may have a slot which locks with theretaining feature on the interior surface of the longitudinal passageafter the catheter assembly has been rotated. Thus, in a single motionof rotating the catheter assembly, the catheter assembly both locks tothe retaining feature and releases the needle so that the needle isautomatically retracted by expansion of the spring.

In other specific aspects of the catheter insertion apparatus, once theneedle has been fully retracted within the housing and the catheterfully advanced from the housing, the integrated apparatus may be tapedto the patient and connected to any conventional fluid or othermedicament source. There is no need to detach the needle, and the needleis fully protected and locked within the housing, thus presenting nosafety issues.

In still further aspects of the present invention, a method is providedfor inserting a catheter into a vein of a patient. A needle on a housingis manually advanced into the vein, where the needle and the housingcarry a retracted catheter. The catheter is then manually advanced fromthe needle into the vein, and the needle is retracted over the catheterinto the housing while the catheter remains in the vein. Once the needleis within the housing, the housing may be secured to skin of the patientand is available for connection to a conventional fluid delivery orother medicament system.

In particular aspects of the method, the needle remains fully retractedwithin the housing when the housing is secured to the skin of thepatient. The needle may be retracted manually, e.g. where the userretracts the slider on the housing. Alternatively, the needle may beretracted automatically, e.g. by releasing a constrained spring toaxially translate the needle relative to the catheter and the housing.

In still other embodiments, automatic needle retraction can be affectedby mechanically coupling the catheter assembly to the needle, thusaccomplishing “automatic” needle retraction while eliminating the needfor a spring. For example, a pulley assembly can be provided byattaching a pulling end of one or more tethers to the needle and adriving end of each tether to the catheter, The tether will be passedover a “pulley” feature on the body so that the pulling end of thetethers travels proximally to draw the needle proximally into thehousing as the driving ends of the tethers are translated distally asthe catheter is pushed forward.

In still other instances, an elastic band or other element may beattached to the needle and the housing and loaded under tension. Thetensioned element may then be automatically or manually released todrive the needle proximally into the housing.

In a third exemplary embodiment of the present invention, an integratedcatheter comprises, and in preferred instances consists of, a housing, aneedle cannula, a venous access catheter, and a spring configured toautomatically retract the needle after the venous access catheter hasbeen advanced through the needle.

In particular, the catheter insertion apparatus may comprise or consistof a housing having a longitudinal passage and a cannula or other needleassembly slidably mounted within the longitudinal passage of thehousing. The longitudinal passage typically extends from a proximalextension to a distal end of the housing, and the needle cannula extendsfrom a proximal hub to a tissue-penetrating distal tip. In an initialconfiguration, the needle cannula extends distally from the distal endof the housing, fully exposing the tissue-penetrating distal tip toallow percutaneous introduction to a patient's venous lumen.

The venous access catheter is typically formed as an assembly includinga catheter body or shaft having a distal port and being slidably mountedwithin the needle lumen, a proximal connector, and at least one armextending distally from the proximal connector. The catheter shaft isproximally disposed (retracted) within the needle lumen when thecatheter insertion apparatus is in its initial configuration. The springtypically comprises an axially compressed coil spring disposed coaxiallyover the proximal hub or other portion of the needle cannula, where adistal end of the spring engages an interior surface of the longitudinalpassage of the housing and a proximal end of the spring engages a distalface of the proximal hub of the needle when the catheter insertionapparatus is in its initial configuration. A latch on the needle hubengages a locking feature on an inner surface of the longitudinalpassage of the housing to hold the needle in place against the force ofthe compressed spring, wherein the at least one arm of the catheterassembly is configured to disengage the latch from the locking featureafter the catheter is distally advanced to allow the spring todecompress and retract the needle into the housing

In specific instances of the third embodiment of the catheter insertionapparatus, the needle assembly may comprise a needle hub having at leastone spring-loaded latch which engages the locking feature on the insidesurface of the longitudinal passage in the housing to hold the needle inplace where the at least one arm engages and releases the at least onespring-loaded latch from the locking feature as the catheter isadvanced. The at least one spring-loaded latch may comprise acantilevered hook on the needle hub, and the locking feature maycomprise an undercut or other slot formed on the inside surface of thelongitudinal passage in the housing. The proximal connector of thecatheter typically comprises a female luer taper and the proximalextension of the housing typically comprises male luer threads, whereinthe female luer taper and the male luer threads are joined to form acomplete luer fitting when the catheter is fully advanced through thehousing. In most instances, the housing is configured to be taped to apatient after the needle has been retracted.

In a further aspect, the present invention provides a catheter insertionsystem which includes both a catheter insertion device and a catheter tobe inserted into a patient's venous system using the catheter insertiondevice. The catheter insertion device comprises a housing extendingalong a longitudinal axis and a needle extending distally, usuallycoaxially, from a distal end of the housing. The needle will have alongitudinal passage which is coaxially aligned with the longitudinalaxis of the housing. The catheter has a length and is sized and shapedto be advanced from a retracted position within the longitudinal passageof the needle to an extended position when at least a portion, typicallyone-half or more, of the catheter length extends beyond a distal tip ofthe needle.

In particular aspects of the present invention, the catheter has adistal port configured to direct an outlet flow in a lateral direction(relative to the axial direction of the needle). The distal port has afixed rotational orientation relative to the longitudinal axis of thehousing. In this way, a user can readily control a rotationalorientation of the distal port of the catheter as the catheter is beingadvanced from the needle. Usually, the user will rotationally orient thecatheter insertion device which carries the catheter so that the distalport on the catheter is deployed in a desired rotational orientation inthe venous lumen. Typically, the distal region of the catheter will beadvanced against a wall of the venous lumen and the distal port will beoriented to direct fluid flow from the distal port toward the center ofthe venous lumen. Such orientation is advantageous as it promotes mixingof the fluid with the blood flow.

In further embodiments of the present invention, the housing of thecatheter insertion device may have an upper side and the outflow fromthe distal port of the catheter may be aligned in a direction toward theupper side of the housing. This allows a user to easily control thedirection of the distal port since it will always be aligned with theupper side of the housing which remains visible at all times duringcatheter deployment.

In other particular embodiments of the present invention, the port maybe configured to orient the outlet flow at an angle in a range from 30°to 75° relatively to a longitudinal access of the catheter near itsdistal end.

In other specific aspects, the catheter may have an atraumatic tip, suchas a bullet tip and the outlet port may be formed by a chamfer angled onone side of the bullet tip.

In still other particular embodiments of the present invention, thecatheter may have an advancer (typically on a proximal hub) which isdisposed through a channel in the upper side of the housing so that theadvancer is aligned with the outlet flow of the distal port. The needlemay be retractable into the housing so that the housing may be securedto a patient without removing the needle. Alternatively, the housing andthe needle may both be “splittable” to facilitate removal of the housingand needle from the catheter after the catheter has been introduced intoa vein, as described in US2019/0076628, commonly assigned with thepresent application, the full disclosure of which is incorporated hereinby reference.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

The invention will be understood from the following description ofpreferred embodiments, taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is a perspective view of a top view of a catheter insertiondevice constructed in accordance with the principles of the presentinvention.

FIG. 2 is a side view of the catheter insertion device of FIG. 1.

FIG. 3 illustrates a venous catheter having an atraumatic distal tipwith a laterally offset outlet port that may be delivered using thecatheter insertion tools of the present invention.

FIG. 4 is a detailed view of the distal end of the venous catheter ofFIG. 3.

FIG. 5 is a detailed view of the distal end of the venous catheter ofFIG. 5, shown in cross-section.

FIGS. 6A-6C illustrate use of the catheter insertion tools of FIGS. 1and 2 for delivering a venous catheter into a venous lumen.

FIG. 7 is a perspective view of an integrated catheter insertionapparatus constructed in accordance with the principles of the presentinvention.

FIGS. 8A-8C illustrate the integrated catheter insertion apparatus ofFIG. 7 showing the steps in deploying a catheter and retracting a needlein accordance with the principles of the methods of the presentinvention.

FIG. 9 is an exploded view illustrating the various components of theintegrated catheter insertion apparatus of FIG. 7.

FIGS. 10A and 10B illustrate details of the spring-loaded needleretraction assembly of the present invention.

FIGS. 11A-11C illustrate the steps of the methods of the presentinvention for advancing the venous access catheter and retracting thevenous access needle in accordance with the methods of the presentinvention.

FIGS. 12A-12C are cross-sectional views taken along lines 12A-12A,12B-12B, and 12C-12C, in FIGS. 11A-11C.

FIGS. 13A and 13B are perspective views of a further embodiment of anintegrated catheter insertion apparatus constructed in accordance withthe principles of the present invention shown in full view andcross-sectional view, respectively.

FIG. 14 is an exploded view illustrating the various components of theintegrated catheter insertion apparatus of FIGS. 13A and 13B.

FIG. 15 is a perspective view of a housing of the integrated catheterinsertion apparatus of FIGS. 13A and 13B.

FIGS. 15A and 15B are detailed views of a partial luer fittingincorporated into a proximal end of the housing of FIG. 15 shown in fullview and cross-sectional view, respectively.

FIG. 16 is a perspective view of a cannula of the integrated catheterinsertion apparatus of FIGS. 13A and 13B.

FIGS. 16A-16C are detailed views of a hub disposed at a proximal end ofthe cannula illustrated in FIG. 16.

FIGS. 17A and 17B are detailed views illustrating how the partial luerfitting incorporated into the proximal end of the housing of FIG. 15mates with a partial luer fitting incorporated into a proximal end of acatheter assembly to form a complete luer fitting.

FIG. 18 is a cross-sectional view of the housing illustrating channelsformed into an internal wall of the housing which receive two arms ofthe catheter assembly to allow advancement and alignment of the catheterassembly in the housing.

FIGS. 19A-19C illustrate method steps of the present invention fordeploying the integrated catheter insertion apparatus of FIGS. 13A and13B in accordance with the principles of the present invention, shownwith the integrated catheter insertion apparatus in a top,cross-sectional view.

FIGS. 20A-20C illustrate method steps of the present invention fordeploying the integrated catheter insertion apparatus of FIGS. 13A and13B in accordance with the principles of the present invention, shownwith the integrated catheter insertion apparatus in a side,cross-sectional view.

FIGS. 21A and 21B illustrate the integrated catheter insertion apparatusof FIGS. 13A and 13B after the catheter has been introduced into a veinand the cannula retracted into the housing.

FIGS. 22A-22C illustrate an optional blood control valve disposed in thecatheter hub which opens from a proximal, closed configuration (FIG.22A) to a distal, open confirmation (FIG. 22C) as it is distallyadvanced in a passage of the hub by attachment of an external luerconnector.

DETAILED DESCRIPTION OF THE INVENTION

The illustrations presented herein are not actual views of anyparticular catheter insertion device but are merely idealizedrepresentations employed to describe example embodiments of the presentdisclosure. The following description provides specific details ofembodiments of the present disclosure in order to provide a thoroughdescription thereof. However, a person of ordinary skill in the art willunderstand that the embodiments of the disclosure may be practicedwithout employing many such specific details. Indeed, the embodiments ofthe disclosure may be practiced in conjunction with conventionaltechniques employed in the industry. In addition, the descriptionprovided below does not include all elements to form a completestructure or assembly. Only those process acts and structures necessaryto understand the embodiments of the disclosure are described in detailbelow. Additional conventional acts and structures may be used. Alsonote, any drawings accompanying the application are for illustrativepurposes only and are thus not drawn to scale. Additionally, elementscommon between figures may have corresponding numerical designations.

As used herein, the terms “comprising,” “including,” and grammaticalequivalents thereof are inclusive or open-ended terms that do notexclude additional, un-recited elements or method steps, but alsoinclude the more restrictive terms “consisting of,” “consistingessentially of,” and grammatical equivalents thereof.

As used herein, the term “may” with respect to a material, structure,feature, or method act indicates that such is contemplated for use inimplementation of an embodiment of the disclosure, and such term is usedin preference to the more restrictive term “is” so as to avoid anyimplication that other compatible materials, structures, features, andmethods usable in combination therewith should or must be excluded.

As used herein, the term “configured” refers to a size, shape, materialcomposition, and arrangement of one or more of at least one structureand at least one apparatus facilitating operation of one or more of thestructure and the apparatus in a predetermined way.

As used herein, the singular forms following “a,” “an,” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise.

As used herein, the term “and/or” includes any and all combinations ofone or more of the associated listed items.

As used herein, spatially relative terms, such as “below,” “lower,”“bottom,” “above,” “upper,” “top,” and the like, may be used for ease ofdescription to describe one element's or feature's relationship toanother element(s) or feature(s) as illustrated in the figures. Unlessotherwise specified, the spatially relative terms are intended toencompass different orientations of the materials in addition to theorientation depicted in the figures. For example, the spatially relativeterms may refer to a catheter insertion device when the device isdisposed on a horizontal surface (e.g., the position depicted in FIG.1).

As used herein, the term “substantially” in reference to a givenparameter, property, or condition means and includes to a degree thatone of ordinary skill in the art would understand that the givenparameter, property, or condition is met with a degree of variance, suchas within acceptable manufacturing tolerances. By way of example,depending on the particular parameter, property, or condition that issubstantially met, the parameter, property, or condition may be at least90.0% met, at least 95.0% met, at least 99.0% met, or even at least99.9% met.

As used herein, the term “vascular catheter” means and includes anycatheter that may be used for providing access to the vasculature, suchas one or more veins or one or more arteries of a patient, such as amidline catheter, a basilic catheter, a cephalic catheter, a centesiscatheter (for deployment in the thoracic or abdominal regions of apatient), or another type of catheter. Vascular catheters describedherein may comprise an arterial catheter or a venous catheter.

Referring to FIGS. 1 and 2, a catheter insertion tool 10 comprises ahousing 12 and a needle 14. The needle has a sharp distal tip 16 toallow transcutaneous insertion through a patient's skin into a vessellumen, such as a venous lumen. The sharp distal tip 16 defines anopening 18 at the distal end of a needle lumen through which a catheterwill be introduced into the venous or other vessel lumen, as will bedescribed in more detail below.

A slider 20 is slidably mounted on a surface of the housing 12. Theslider 20 is coupled at or near a proximal end of the needle 14 to allowa user to manually retract the needle into an interior space within thehousing, as will be described further below. Typically, the slider 20will be connected through an axial slot 21 or other feature formed inthe surface of the housing 12.

A catheter 22 is slidably mounted within the housing 12. Catheter 22will have a proximal housing 24, typically being or including a luerconnector, and a distal tip 30, typically a bullet tip as described inmore detail elsewhere herein. Catheter 22 is free to move within thehousing 12 and the needle 14 so that it may be manually advanced bypushing on the catheter, typically pushing in a proximal direction onthe proximal housing 24. To prevent such movement during needleinsertion, however, a locking sheath 28 is provided around a proximalportion of the catheter 22. So long as the locking sheath 28 is inplace, as illustrated in FIGS. 1 and 2, the distal tip 30 of thecatheter cannot be advanced further into the needle than as shown inbroken line.

Referring now to FIGS. 3, 4, and 5, a bullet-nosed catheter 22 includesa flexible shaft 23 having a bullet-shaped distal tip 30 (e.g. having ahemispherical distal end) and a proximal housing 24, typically a luerfitting. As best seen in FIGS. 4 and 5, a distal outlet port 32 isformed in the bullet-shaped distal tip 30 of the catheter shaft 23 andis oriented at an angle relative to a longitudinal access of the shaftlumen 25. In the illustrated embodiment, the distal outlet port 32 isformed by cutting or “chamfering” a portion of the bullet-shaped distaltip 30 of the catheter shaft. Typically, the chamfer will be formed atan angle α in range from 30° to 75°, as illustrated in FIG. 5. Otherlaterally offset outlet ports could also be used. It is desirable thatonly the outlet port be able to direct fluid from the distal outlet port32 of the catheter shaft 23 at an angle which is laterally offset ordeflected from the longitudinal access of the shaft, as described inmore detail below. This allows the user to orient the outlet flow of thecatheter 22 so that it will be directed across blood flow to promotemixing in the vein.

In exemplary embodiments, the length of the needle 14 be in a range from1.5 cm to 5 cm, typically being in a range from 2.5 cm to 3.5 cm. Thecatheter shaft 23 may have a length in the range from 6 cm to 20 cm,typically being from 8 cm to 14 cm. In such embodiments, a distal regionof the catheter shaft having a length in the range from 1.5 cm to 6 cm,typically from 2 cm to 4 cm is available to be advanced from the needleand deployed in the patient's vein as described below.

As shown in FIGS. 6A through 6C, the bullet-nose catheter 22 may bedeployed in a patient's venous lumen VL by first choosing a targetinsertion site T on a patient's skin S. A sharp tip 18 on the needle 14is manually pushed through the skin S at the target site T in aconventional manner so that the tip enters the venous lumen VL and maybe positioned generally in the middle of the lumen. The needle willtypically be inserted through the skin S at an angle β relative to thevenous lumen VL, typically in the range from 30° to 45°, as shown inFIG. 6A.

Referring now to FIG. 6B, once the distal tip 18 of the needle is inplace in the venous lumen VL, the locking sheath 28 will be removed fromaround the catheter 22, allowing a user to manually push the luerconnector or other proximal hub 24 or other proximal hub distally sothat a distal region of the catheter 22 enters the venous lumen VL.Typically, the proximal hub will be advanced fully so that it engages aproximal end of the housing 12, as shown in FIG. 6B, but in otherinstances it may be desirable to only partially advance the catheter,resulting in a shorter length of the catheter being within the vessel.

Referring now to FIG. 6C, once the desired length of the catheter hasbeen introduced into the venous lumen VL, the slider 20 will be manuallyretracted in a proximal direction to proximally retract the needle 14fully within an interior space of the housing 12. The proximal hub 24,typically a conventional luer connector, is ready to be connected to anexternal fluid source in the conventional manner. The housing 12 may betaped or otherwise secured to the patient's skin S and the catheter willbe considered fully deployed.

Referring now to FIGS. 7 and 8A-8C, a catheter insertion apparatus 100comprises a housing 102, a cannula 104, typically a needle having asharpened distal tip 114, and a venous access catheter 106. The catheteris part of a catheter assembly including a proximal connector 108 at aproximal end of the catheter. The proximal connector 108 may be aconventional luer-type fitting having proximal threads 116 of the typewhich mate with conventional medical fluid delivery systems. Theproximal connector 108 will typically also have gripping features 118 bwhich eventually line with gripping features 118 a at a proximal end ofthe housing 102, as shown in FIG. 8C.

In an initial configuration (i.e. the configuration used for initialneedle penetration into the patient's vein), the catheter 106 will befully retracted within the needle 104 and the housing 102, as shown inFIGS. 7 and 8A. The proximal connector 108 on the catheter assembly willalso be proximally spaced from a proximal end of the housing 102 whilebeing slidably attached to the housing by a pair of arms 110. The arms110 serve a number of functions, as described below, but as seen inFIGS. 7 and 8A, will act as rails or guides for advancing the catheterassembly into the interior of the housing 102 as the connector 108 ispushed distally by a user.

The catheter insertion apparatus 100 further includes a flashback window112 and a pair of taping wings 120 on the housing 102. Flashback window112 allows the user to detect when blood flows back into the deviceafter the sharpened distal tip 114 first enters a vein, confirming thataccess has been achieved. The taping wings facilitate taping, wrapping,or otherwise securing the housing to the patient after the catheter 106has been positioned in the target vein.

After the needle 104 has been introduced into a vein, typically bymanual placement in a conventional manner, flashback will be observedthrough the window 112, and the catheter 106 will be distally advancedfrom the needle 104 by distally advancing the proximal connector 108, asshown in FIG. 8B. At this point, the catheter 106 will be advanced butthe needle 104 will still be in place and the catheter has not yet beenlocked to the housing. Both retracting the needle 104 and locking thecatheter 106 may be achieved by rotating the proximal connector 108until the gripping features 118 a and 118 b come into axial alignment,as shown in FIG. 8C. While a number of internal mechanisms are necessaryto bring about this change, for the user it is a simple twist of theconnector 108 that both retracts the needle and locks the catheter inplace.

Referring now to FIG. 9, the internal components of the catheterinsertion apparatus 100 will be identified and described. The needle 104is aligned to pass through a distal port 126 in the housing 102 and hasa needle carriage 138 attached to its proximal end. The needle carriage138 has a pair of mating wedges 140 (only one of which is visible inFIG. 9) projecting radially outwardly from its proximal end. A lockingdisc 134 is located on a proximal side on the needle carriage 138 andincludes a pair of locking tabs 136. The arms 110 of the catheterassembly each have a locking slot 130 formed near their respectivedistal ends. A coil spring 124 is disposed between the needle 104 andthe housing 102 so that the spring will be compressed between the needlecarriage 138 and a proximal surface 103 of an internal passage 105(FIGS. 10A and 10B) of the housing 102 when the needle 104 is fullyadvanced relative to the housing, as described in more detail below.

Referring now to FIGS. 10A and 10B, the details of the internal needleretention and release mechanism will be described. In both FIGS. 10A and10B, the needle 104 is fully extended in the distal direction throughthe distal port 126 in the housing 102 and held in place by the lockingdisc 134 which engages and retains the needle carriage 138. Coil spring124 is fully compressed between a distal surface of a retaining flange135 at a proximal end of the needle carriage 138 and the proximalsurface 103 of an internal passage 105 of the housing 102.

The locking disc 134 is held in place by an engagement between lockingtab 136 which extends radially outwardly from the locking disc and ablocking feature 144 formed on an interior surface of the interiorpassage 105 of the housing 102. Rotation of the locking disc 134 about alongitudinal axis of the housing 102 (perpendicular to a plane of thelocking disk) will disengage the locking tab 136 from the blockingfeature 144, allowing the disc to translate proximally propelled byexpansion of the spring 124, releasing the needle carriage 138 andspring 124. The mechanisms required to rotate the locking disc aredescribed in connection with FIGS. 11A-11C and 12A-12C.

FIG. 11A illustrate the needle retention and retraction mechanism in thesame state as shown in FIGS. 10A and 10B. In addition, FIG. 11A showsone arm 110 of the pair of arms which form part of the catheter assemblyshown in FIG. 9. The proximal connector 108 is shown in broken line. Allcomponents of the catheter insertion apparatus 100 shown in FIG. 11A arein their initial configuration where the needle is fully advancedthrough the distal port 126 in the housing 102 and the catheter 106retracted inside of the needle, as shown in FIGS. 7 and 8A.

In order to both advance the catheter 106 and release the locking disc134, the catheter assembly may be distally translated by pushing on theproximal connector 108 to engage a distal surface of the proximalconnector against a proximal end of the housing 102, as shown in FIG.11B. Such axial translation of the connector 108 will fully extend adistal tip of the catheter 106 beyond the sharpened distal tip 114 ofthe needle 104, as shown in FIG. 8B. At this point, however, as shown inFIG. 11B, the needle 104 remains distally advanced through the distalport 126 in the housing 102 and the catheter 106 is not yet locked inplace. In this state, the catheter 106 could be accidentally retractedsimply by pulling on the proximal connector 108 and/or pushing on adistal end of the catheter 106 in a proximal direction.

In order to both lock the catheter 106 to the housing 102 and releasethe locking disc 134 to allow the needle 104 to retract under the forceof spring 124, the proximal connector 108 may be rotated to the positionshown in FIGS. 8C and 11C. Such rotation causes a distal surface 142 ofthe arm 110 to engage and rotationally displace the locking tab 136 onthe locking disc 134. Such rotation takes the locking tab 136 out ofaxial alignment with the blocking feature 144. When the locking tab isdisplaced, the locking disc 134 is free to translate proximally underthe force of the spring 124 which is released from compression.

Simultaneously, as the arm 110 rotates, the locking slot 130 on the armwill engage and lock onto the blocking feature 144 on the interior wallof the housing 102, as shown in FIG. 11C. Such engagement and lockingprevent further axial translation of the catheter assembly. As a furthersafety feature, subsequent rotation of the proximal connector 108 isprevented by capturing the locking tab 136 on the locking disc 134between one side of an alignment rail 148 and an opposing surface of theproximal end of the arm 110, as shown in FIG. 11C. It will beappreciated that the alignment rail 148 acts as a guide for the lockingtab as it is proximally translated by the expansion of spring 124, thusassuring that it is positioned between the alignment rail and the arm110 when the needle is fully retraced and the catheter fully advanced.This safety feature is of a particular advantage as it preventsaccidental release of the needle after the housing has been taped to thepatient and connected to the fluid delivery system.

Positioning of the alignment rails 148 and the arms 110 of catheterassembly during various stages of the operation of the catheterinsertion apparatus 100 can be observed in FIGS. 12A-12C which arecross-sectional views taken along lines 12A-12A, 12B-12B, and 12C-12C ofFIGS. 11A-11C, respectively.

Referring now to FIGS. 13A and 13B, a catheter insertion and attachmentapparatus 200 according to a third embodiment of the present inventioncomprises a housing 202, a needle cannula 204, such as a hypotube needleor similar injection device having a sharpened distal tip 214, and avenous access catheter 206. The venous access catheter 206 is receivedin an axial passage 203 (FIG. 13B) within the housing 202 and has apartial (inner) luer fitting 218 at its proximal end. A pair of arms 210is attached to the partial luer fitting 218 and extend from the fittingin a distal direction parallel to a longitudinal axis of the venousaccess catheter 206. A distal end of each arm 210 terminates in wedgetip 228 which is configured to release the needle cannula 204 fromtemporary attachment to the housing 202 as the catheter 206 is distallyadvanced within the passage 203 of the housing 202. A second partial(outer) luer fitting 208 is formed on a proximal extension 234 at aproximal end of the housing 202. The second partial luer fittingincludes external luer threads 208 a which form the attachment portionof the luer when external tubing is attached to the catheter. Inparticular the luer becomes functional when the inner luer fitting 218is inserted into the outer luer fitting 208 as will be described ingreater detail below. Typically, the housing 202 will include a pair oftaping wings 216 to facilitate securing the housing 202 to the patient'sskin after catheter insertion and needle retraction.

As further shown in FIGS. 13A and 13B, in the initial configuration ofthe catheter insertion and attachment apparatus 200, the needle cannula204 is fully extended in a distal direction from the housing 202 and theaccess catheter 206 is fully retracted in a proximal direction withinthe housing 202. In this configuration, the cannula needle 204 is readyto be percutaneously inserted into a patient's vein. The sharpened thedistal tip 214 is inserted into a lumen of a target vein, and entry isconfirmed by observing flashback in a window 212 formed in a wall of thehousing 202. A complete description of needle insertion, catheteradvancement, needle retraction, and external tubing connection is madewith reference to FIGS. 19A-19C and FIGS. 20A-20C below.

Referring now to FIG. 14, each component of the catheter insertion andattachment apparatus 200 is illustrated in isolation. The catheterinsertion and advancement apparatus 200 will typically consist of onlyfour components. In addition to the housing 202, needle cannula 204, andvenous access catheter 206 described previously, the apparatus 200 willusually include only a coil or other compression spring 224. It is aparticular advantage of this embodiment of the present invention thatonly four separate components are necessary, substantially simplifyingfabrication and assembly of the complete product. As best seen in FIG.14, the partial luer fitting 218 on the access catheter 206 includes aplurality of locking or retention teeth 220 a formed on its outersurface. As seen in FIG. 13B, a plurality of locking or retention teeth220 b are also formed on an inner surface of the proximal extension 234of the housing 202. When the catheter 206 is fully advanced into thehousing 202, the locking teeth 220 a on the partial luer fitting 218will engage the locking teeth 220 b on the proximal extension of thehousing. In this way the teeth 220 a and 220 b, which are formed asinterlocking ratchets, will engage each other and lock or affix thecatheter to the housing to prevent accidental retraction. The venousaccess catheter 206 further includes a distal catheter port 226. Thedistal catheter port 226 may take any conventional form but willtypically have an upward configuration similar to that describepreviously.

As further seen in FIG. 14, the needle cannula 204 has a hub 238 and itsproximal end opposite the sharpened distal tip 214 formed at the distalend. The needle hub 238 has a pair of engagement hooks or tangs 242which serve to “releasably” lock the needle cannula in the distallyforward configuration prior to retraction of the needle after thecatheter has been advanced, as will be described in greater detailbelow.

Referring now to FIGS. 15, 15A, and 15B, the proximal extension 234 ofthe housing 202 will be described in greater detail. The proximalextension 234 comprises a pair of semi-cylindrical shell elements 232having a pair of laterally opposed gaps 230 therebetween. The luerthreads 208 extend around the semi-cylindrical shell elements 232 andover the gap 230, allowing the wedge tips 228 on the arms 210 of thevenous access catheter 206 to be advanced beneath the external threads208 and through channels 250 on an inner wall of the axial passage 203of the housing 202, as best seen in FIG. 18. In this way, the wedge tips228 can be advanced to the needle cannula hub 238 as the catheter 206 isbeing advanced through the needle cannula 204. When the wedge tips 228reach the needle cannula hub 238, they will disengage the needle cannulahub from the housing wall, as described in more detail below, allowingthe compressed spring 224 to decompress and retract the needleproximally over the venous access catheter 206 and into the axialpassage 203 of the housing 202.

Referring now to FIGS. 16 and 16A-16C, the needle cannula assembly 204will be described in greater detail. The needle cannula assembly 204includes a conventional needle shaft 204 a having a sharpened distal tip214 at its distal end. The cannula hub 238 is attached to a proximal endof the shaft 204 and comprises a cylindrical wall having a pair ofopposed cantilever spring elements 240 formed therein. The cantileversprings are attached to the wall at their distal ends so that theengagement hooks or tangs 242 at their proximal ends maybe resilientlycompressed inwardly to release the needle hub from engagement with thehousing wall, as will be described below. Each tang or hook 242 has abeveled surface 244 which is configured to be engaged and compressed bythe wedge tips 228 of the arms 210 to effect the desired release. Asshown in FIG. 16 C, the spring coil 224 is maintained in a compressedconfiguration prior to release of the needle for retraction into thehousing. Release of the needle cannula hub 238 from engagement with thehousing 202 allows the spring 224 to decompress and drive the needlecannula assembly 204 proximally so that it fully retracts into thehousing prior to attachment of external tubing.

Referring now to FIGS. 17A and 17B, engagement between the partial luerfitting 218 on the venous access catheter 206 with the partial luerfitting 208 on the housing 202 will be described. In FIG. 17A, thepartial luer fitting 218 has been advanced to a point where the lockingteeth 220 a are just about to enter an interior of the proximalextension 234 of the housing 202. It can be seen that arms 210 areentering the housing 202 through the gaps 230 present in the wall of theproximal extension 234. In particular, the arms 210 pass beneath theluer threads 208. Once the partial luer fitting 208 on the catheter 206is fully advanced into the proximal extension 234, the combination ofthe partial luer fittings 208 and 218 will form a complete male luerfitting suitable for attachment to a conventional female luer fitting ascommonly found on medical tubing. After full insertion of the catheter206 into the housing 202, the locking teeth 220 a on the partial luerfitting 218 will engage the locking teeth 220 b (FIG. 15B) on the innersurface of the proximal extension 234. In this way, the catheter will belocked in place within the housing.

FIG. 18 shows a cross-sectional view of the needle cannula 204 andcatheter assembly 206 present in the housing 202. In particular, it canbe seen that arms 210 are advanced through channels 250 formed on theinner wall of the axial passage 203 within the housing 202. As shown inFIG. 18, the venous access catheter 206 remains within an inner lumen ofthe needle cannula 204 after the catheter has been advance and theneedle catheter retracted.

Referring now to FIGS. 19A-19C and 20A-20C, step-wise advancement of thecatheter assembly 206 in to the housing 202 and retraction of the needlecannula 204 into the housing will be described. As shown in FIG. 19A,the sharpened distal tip 214 of the needle cannula 204 extends fullydistally of the housing 202 and is ready for insertion through thepatient's skin into the venous lumen. At this point, the catheterassembly 206 is fully retracted in a proximal direction and held inplace by engagement of the wedge tips 228 of the arms 210 with theproximal extension 234 of the housing 202. The wedge tips 228 on thedistal ends of the arms are initially located beneath the lower threads208 and are disposed in the gap 230.

After the needle 204 has been advanced into the venous lumen, thecatheter 206 is advanced into the venous lumen by distally pushing thepartial luer fitting 218 into the partial luer fitting 208 formed on theproximal extension 234 of the housing, as shown in FIGS. 19B and 20B.The external lower threads 208 are disposed over the exterior of thepartial lower fitting 218 in one orientation (FIG. 19B) and are attachedto the semi-cylindrical elements of the proximal extension in anotherorientation (FIG. 20B). As the wedge tips 228 are distally advanced,they engage the engagement hooks or tangs 242 on the needle hub 238. Inparticular, the inclined surfaces of the wedge tips 228 engage thebeveled surfaces 244 (FIGS. 16A and 16B) of the cantilever springs 240forcing the springs inwardly and disengaging the engagement hooks ortangs 242 from retention slots 252 formed on the inner wall of the axialpassage 203 of the housing 202, as best seen in FIG. 19B. Once theengagement hooks 242 are released from the engagement slots 252, theneedle hub 238 will be released to translate freely, and the compressedspring 224 will decompress to translate the needle hub 238 proximally,retracting the needle cannula 204 fully into the housing, as shown andFIGS. 19C and 20C.

Referring now to FIGS. 21A and 21B, placement of the catheter 206 intothe lumen of a vein V is accomplished by advancing the needlepercutaneously through the patient's skin S, further advancing thecatheter into the vein lumen, and then retracting the needle, as justdescribed. In a preferred embodiment, the distal port 226 of thecatheter 206 will be oriented upwardly to provide the advantagesdescribed previously in this patent application.

Referring now to FIGS. 22A to 22C, an alternative hub 318 typicallyformed as an inner luer fitting (shown without an outer luer fitting forsimplicity of illustration) may be modified by increasing it length(relative to previously illustrated inner luer fitting 218 a) andproviding a male post 320 defining a blood outlet port 322 on a distalsurface 324 of an interior axial passage 330 thereof. A blood controlvalve 328 having a split valve element 334 may be translatably disposedin the axial passage 330 of the inner luer fitting 318. The bloodcontrol valve 328 is typically formed from a blood-compatible polymer,such as a silicone polymer, and may conveniently have a “top-hat”configuration with a rim 332 formed circumferentially about its proximalend with the split valve element 334 formed in a distal surface thereof.The rim 332 is configured to act as both a seal and a bearing surfacethat allows the blood control valve 328 to be advanced from a proximallocation, as shown in FIG. 22A, to a distal location, as shown in FIG.22C. As described in more detail below, the split valve element 334closed as the needle initially penetrates the target vein or other bloodvessel to allow blood flashback and gas venting but inhibit bloodleakage from the hub. After penetration is confirmed by observing theflashback, an external IV connector 340 or other connector is attachedto the inner luer fitting.

The external IV connector 340 is typically attached to a fluid deliverytube 342 which may be connected to a conventional saline or other fluiddelivery bag (not shown). As shown in FIG. 22B, the external IVconnector 340 has an internal male rod 344, typically molded into thebody of the external IV connector 340, having a central lumen 346 whichcan receive a fluid flow from the tube 342 when such flow has beeninitiated. As a needle (e.g. needle 204 in FIG. 16) is inserted distallyinto a target vein or other patient blood vessel, blood will flowproximally through the needle lumen into the hub 318 which willtypically be transparent or have a transparent window to allow a user toobserve blood “flashback” confirming that the needle has entered theblood vessel. The split valve element 334 of the blood control valve 328allows gas initially present in the hub 318 to vent while inhibitingblood loss from the hub. To open the valve element to allow infusion, atip 344 a of the male rod 344 engages the rim 332 of the blood controlvalve 328 to push the split valve element 334 against the male post 320which forces the split valve element to open, as shown in FIG. 22C. Thesilicone or other polymeric material of the valve element will bedisplaced to fit around the male post inside the catheter assembly huband will remain there for the remainder of the procedure.

While the present invention has been described herein with respect tocertain illustrated embodiments, those of ordinary skill in the art willrecognize and appreciate that it is not so limited. Rather, manyadditions, deletions, and modifications to the illustrated embodimentsmay be made without departing from the scope of the invention asclaimed, including legal equivalents thereof. In addition, features fromone embodiment may be combined with features of another embodiment whilestill being encompassed within the scope of the invention ascontemplated by the inventors. Further, embodiments of the disclosurehave utility with different and various tool types and configurations.

What is claimed is:
 1. An integrated catheter insertion apparatus,comprising: a housing having a longitudinal passage; a needle slidablymounted within the longitudinal passage of the housing and having anaxial lumen extending from a proximal end to a tissue-penetrating distaltip, wherein the needle extends distally from a distal end of thehousing in an initial configuration of the catheter insertion apparatusand wherein the needle is held in place by a releasable latch; and acatheter slidably mounted within the needle lumen and having a distalport and a proximal connector, wherein the catheter is proximallyretracted within the needle in the initial configuration of the catheterinsertion apparatus, wherein the catheter is configured to release thereleasable latch to allow the needle to retract when the catheter isfully advanced within the needle lumen; wherein the proximal connectorof the catheter is distally advanceable to a proximal end of the housingto extend the distal port of the catheter distally from the distal tipof the needle; and wherein the needle is fully retractable within thehousing.
 2. The catheter insertion apparatus of claim 1, wherein theneedle comprises a proximal hub and the releasable latch comprises atleast one spring-loaded latch element which engages a locking feature onan inside surface of the longitudinal passage in the housing to hold theneedle in place and wherein the catheter comprises at least one latchrelease feature which engages and releases the at least onespring-loaded latch element as the catheter is advanced.
 3. The catheterinsertion apparatus of claim 2, wherein the at least one spring-loadedlatch element comprises a cantilevered hook on the needle hub and thelocking feature comprises an undercut on the inside surface of thelongitudinal passage in the housing.
 4. The catheter insertion apparatusof claim 1, further comprising a spring assembly within the longitudinalpassage of the housing configured to retract the needle after thecatheter has been distally advanced from the needle.
 5. The catheterinsertion apparatus of claim 4, wherein the spring assembly isconfigured to automatically retract the needle after the catheter hasbeen distally advanced from the needle.
 6. The catheter insertionapparatus of claim 5, wherein the spring assembly comprises a coildisposed coaxially over the needle; wherein the releasable latch holdsthe needle in the needle's distally advanced position with a spring inan axially compressed configuration, wherein release of the releasablelatch allows the spring to axially expand to cause the needle toretract.
 7. The catheter insertion apparatus of claim 6, wherein thereleasable latch is configured to automatically release the spring whenthe catheter is fully advanced.
 8. The catheter insertion apparatus ofclaim 1, wherein the catheter locks to the housing after the catheterhas been fully advanced.
 9. The catheter insertion apparatus of claim 1,wherein the housing is configured to be taped to a patient after theneedle has been retracted.
 10. The catheter insertion apparatus of claim1, wherein the proximal connector of the catheter comprises a luerfitting.
 11. The catheter insertion apparatus of claim 1, wherein theproximal connector of the catheter comprises a female luer taper and aproximal portion of the housing comprises male luer threads, wherein thefemale luer taper and the male luer threads are joined to form acomplete luer fitting when the catheter is fully advanced through thehousing.
 12. The catheter insertion apparatus of claim 1, furthercomprising a valve in the proximal connector configured to open inresponse to engagement with an external connector when the externalconnector is attached to the proximal connector.
 13. The catheterinsertion apparatus of claim 12, wherein the valve in the proximalconnector comprises a split valve that opens when advanced distallyagainst a male fitting in an axial passage in the proximal connector.